AccessCR links to a piece from Epoch Times about fraudulent trials producing clinical data for some of the more popular asthma drugs out there, like Serevent, Singulair, Flovent, etc., etc., according to charges brought by a former sub-investigator on the trials named Dr. Robert Davidson. According to the piece,"Davidson charges that during aggressive recruitment schemes in the late 1990s, patients with abnormal EKGs, multiple risk factors for coronary artery disease, arrhythmias, pulmonary embolisms, rheumatic fever histories, acute illnesses, and even pituitary tumors were enrolled with impunity in trials that earned investigators as much as $10,000 per patient."
The article quotes FDA inspection reports that cite dry-labbed patient diary cards, investigators who were advised not to state the risks to potential subjects, investigators pressuring patients to participate against their wishes, patients enrolled in clear violation of entry criteria, and on and on. I searched the FDA's warning letter listings but was unable to turn up the documents, so I will have to take Epoch Times at their word. FDA has since mandated new safety warnings in the labels of several of these drugs.
Yikes. I often use the analogy with my students of plane crashes. Transportation safety people study plane crashes because in doing so they learn to make air travel safer than by studying the hundreds of thousands of flights that go off unremarkably every year. However focusing on air crashes, especially in today's intense news cycle, can make them seem a lot more common than they are, and the public can lose sight of the fact that airplanes simply do not fall out of the sky without warning or reason, although after what happened to Air France this week, that possibility seems frighteningly more likely than it should. In teaching future clinical research professionals, we focus on the bad things, like Robert Fiddes, or the Jesse Gelsinger case, so we can learn what to be on guard for, and it can seem like there are only bad things and bad actors. This story adds fuel to that fire.
AccessCR is a nice resource out of Australia whose biweekly email updates should be of interest to clinical research professionals. It is free. According to their website they offer international perspectives on regulatory issues, public perceptions, trials discontinued for whatever region and regional news from the hot emerging markets as well as the more tired old ones, and industry news, all conveyed with a bit of unmistakable Aussie flair. I read it as soon as it comes out.
In other news, there were signs this week of fallout in the US IRB space from the Coast affair. Over a small technicality, all of a sponsor's study screening activities in entire state were brought to a screeching halt. I can't share much detail without disclosing potentially proprietary information, but it seems very clear - at least to me - that the IRB over-reacted to their own mistake in approving a consent several months ago without certain technical elements having to do with state privacy laws and went into box-checking mode, rescinding their previous approval and shutting down patient screening activities until those elements - none of which had anything to do with safety or procedures or even confidentiality of patient information - were added. The best part was that, again according to state law, which the IRB was unable to cite upon request, these elements needed to be presented in the consent document in - wait for it - 14 point font. Yes. Patient screening activities suspended not for safety concerns, but for font size. I fear that we are in store for much more of this kind of over-reaction and box-checking mentality from US IRBs if they even think that what happened to Coast could happen to them as well. And why couldn't it? In a Kafka-esque world such as Coast found themselves, anything is possible.
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